US appeals court issues temporary injunction against Hanmi’s 505(b)2 NDA Esomeprazole Strontium
2013-09-13 · AstraZeneca · original astrazeneca.com ↗
Friday, 13 September 2013 AstraZeneca today announced that the US Court of Appeals for the Federal Circuit has issued a temporary injunction against the US launch of Hanmi's 505(b)2 NDA Esomeprazole Strontium product. NOTES FOR EDITORS About the underlying litigation In June 2013, AstraZeneca entered into an agreement with Hanmi Pharmaceutical and affiliates (“Hanmi”) and Amneal Pharmaceuticals (“Amneal”) to streamline litigation issues regarding Hanmi’s proposed Esomeprazole Strontium 505(b)2 NDA product. Under terms of the agreement, Amneal and Hanmi have conceded the validity and enforceability of AstraZeneca’s US Patent Nos. 5,714,504 and 5,877,192 that protect Nexium. The US District Court for the District of New Jersey (“District Court”) will enter a Consent Judgment. In July 2013, AstraZeneca filed a Notice of Appeal in the US Court of Appeals for the Federal Circuit (“Federal Circuit”) regarding critical aspects of the District Court’s December 2012 construction. Among issues, AstraZeneca is seeking a reversal of claim construction. On 6 August, Hanmi Pharmaceuticals received US FDA approval for Esomeprazole Strontium. About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com CONTACTS Media Enquiries Esra Erkal-Paler (UK/Global) +44 20 7604 8030 Vanessa Rhodes (UK/Global) +44 20 7604 8037 Michele Meixell (US) +1 302 885 6351 Jacob Lund (Sweden) +46 8 553 260 20 Investor Enquiries Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Karl Hård +44 20 7604 8123 mob: +44 7789 654364 Colleen Proctor +1 302 886 1842 mob: +1 302 357 4882 Anthony Brown +44 20 7604 8067 mob: +44 7585 404943 Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729
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